Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Budesonide was not genotoxic in the Ames test, the mouse lymphoma cell forward gene mutation (TK+/-) test, the human lymphocyte chromosome aberration test, the Drosophila melanogaster sex-linked recessive lethality test, the rat hepatocyte UDS test and the mouse micronucleus test.

Short description of key information:
Read-across from supporting substance Budesonide (CAS 51333-22-3)

Endpoint Conclusion:

Justification for classification or non-classification

Based on avaliable data on the supporting substance Budesonide, the substance "Pregna-1,4-diene-3,20-dione, 9,11-epoxy-21-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (9β,11β,16α)- (9CI)" was not classified as mutagen.